100s of UK herbals face ban as registration deadline looms

Hundreds of botanical products face removal from the UK market if
their manufacturers do not submit applications to have them
registered under the European Union Traditional Herbal Medicinal
Products Directive (THMPD) directive.

The British Herbal Medicines Association (BHMA) has urged companies
to begin the registration process or allow products to face market
extinction come the April 2011 deadline.
At that point all herbal products not deemed foodstuffs such as
'spice rack' herbs like garlic or rosemary or, at the other end of
spectrum, those that are deemed medicines, must be registered under
the THMPD.
In the UK, this process is being conducted by the Medicines and
Healthcare products Regulatory Agency (MHRA) which has approved 14
applications since 2005 and has another 21 applications in
lieu.
Pre-flood? ​
Yet the UK is the most advanced member state in this area - along
with Germany and Ireland - which account for the bulk of
registrations since the THMPD was enacted in 2005.
BHMA said 100 registration applications had been lodged by October
2007, the most recent figures it could gather.
Some member states have registered no products so far, with others
still to transpose the THMPD into their national
legislatures.
A BHMA spokesperson told NutraIngredients.com 35
applications "was a remarkably small number"​ despite
the MHRA being as "helpful as it possibly
could". ​​He said he did not know of any
registrations that had been granted in other member states which he
described as "an extraordinary situation". ​
​"What the enforcement situation will be in 2011
remains to be seen," he said. "It could be rather hard on some
companies. We hope there will be a flood of applications but we
have no further statistics at the
moment." ​​Deadline
pressure ​​MHRA senior press officer
Stephen Hallworth said MHRA was working closely with industry to
ensure transparency in regard to the status of the Directive and to
assist companies going through the registration process.
​"We have gone out to talk to industry and let
them know what the Directive is asking of them,"​ he said.
"We look forward to seeing more and more applications as the
deadline draws closer." ​​Hallworth said
companies should note that registration in one member state does
not apply across the bloc and that registrations must be sought in
each member state in which a company sought to market its products
with THMPD registrations.
The 14 approvals have been granted to four manufacturers with seven
being handed to German pharma group-owned MedicHerb.
The last registration approved by the MHRA was for a St John's wort
product manufactured by Bioforce.
Further approvals include two other St John's wort products, two
devil's claw products, two valerian products, an arnica product, a
black cohosh product, a horse chestnut product and a saw palmetto
product.